BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    3.6V PROFESSIONAL OPHTH HEAD ONLY

    DI: 05055272700764 · Model: 1128-P-1004 · KEELER LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    3.6V PROFESSIONAL OPHTH HEAD ONLY
    Primary DI
    05055272700764
    Version / Model
    1128-P-1004
    Company Name
    KEELER LIMITED
    Labeler DUNS
    210164398
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-26
    Public Version
    5
    Public Version Date
    2023-12-05
    Public Version Status
    Update
    Public Device Record Key
    58dbcd3b-031d-4165-b8ec-1679a4da0a60

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HLI Ophthalmoscope, Ac-Powered

    GMDN Terms

    Code Name
    46786 Direct ophthalmoscope

    Identifiers

    Type ID
    Primary 05055272700764